预约演示
更新于：2026-08-31
Amulirafusp alfa
阿沐瑞芙普α
更新于：2026-08-31
概要
基本信息
药物类型 双特异性抗体、抗体融合蛋白 |
别名 IMC-002、IMM 0306、IMM0306S |
作用方式 抑制剂 |
作用机制 CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、CD47抑制剂(分化群47抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构 |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 27145L
来源: *****
Sequence Code 523903788H
来源: *****
关联
10
项与 阿沐瑞芙普α 相关的临床试验NCT07621939
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of IMM0306 in Participants With IgG4-Related Disease (IgG4-RD)
NCT07355283
A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
CTR20242914
一项评估IMC-002治疗活动性系统性红斑狼疮的安全性和有效性的多中心、随机、双盲、安慰剂对照的Ib/II期临床研究
100 项与 阿沐瑞芙普α 相关的临床结果
登录后查看更多信息
100 项与 阿沐瑞芙普α 相关的转化医学
登录后查看更多信息
100 项与 阿沐瑞芙普α 相关的专利（医药）
登录后查看更多信息
2
项与 阿沐瑞芙普α 相关的文献（医药）Journal of Hematology & Oncology
Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study
Article
作者: Shi, Yuankai ; Li, Zhiming ; Song, Yongping ; Zhou, Keshu ; Zhang, Mingzhi ; Wang, Zhen ; Yu, Li ; Meng, Wei ; Yang, Jianliang ; Jing, Hongmei ; Lu, Qiying ; Tian, Wenzhi
BACKGROUND:
Amulirafusp alfa (IMM0306) is a fusion protein of CD47 binding domain of signal-regulatory protein alpha (SIRPα) with CD20 monoclonal antibody on both heavy chains. This study aimed to evaluate the safety and preliminary efficacy of amulirafusp alfa in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL).
METHODS:
We enrolled patients with CD20 + r/r B-NHL who had previously received at least two lines of therapy to receive a single-dose of amulirafusp alfa in the first 2 weeks, followed by a multiple-dose period, in which the patients received the same intravenous dose every week in 4-week cycles. The primary endpoints were to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of amulirafusp alfa.
RESULTS:
Between May 22, 2020 and February 10, 2022, 48 patients with r/r B-NHL were enrolled and received amulirafusp alfa at the doses of 40-2000 μg/kg. As of the data cut-off date of April 18, 2024, no dose-limiting toxicity was observed, and the MTD was not reached. The dose of 2000 μg/kg was identified as the RP2D. All grades and ≥ grade 3 treatment-related adverse events (TRAEs) occurred in 48 (100%) and 33 (68.8%) patients, respectively. The most common ≥ grade 3 TRAEs were lymphocyte count decreased (28/48, 58.3%), white blood cell count decreased (10/48, 20.8%), absolute neutrophil count decreased (9/48, 18.8%) and anemia (5/48, 10.4%). At the doses of 800-2000 μg/kg, objective response rate in follicular lymphoma and marginal zone lymphoma was 41.2% (7/17, 95% confidence interval [CI] 18.4-67.1) and 33.3% (2/6, 95% CI 3.7-71.0), respectively.
CONCLUSION:
Amulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943.
HAEMATOLOGICA
Lymphoma cell-driven IL-16 is expressed in activated B-cell-like diffuse large Bcell lymphomas and regulates the pro-tumor microenvironment
Article
作者: Hao, Mu ; Li, Ru ; Wang, Jingya ; Qiu, Lugui ; Guan, Xuwen ; Fang, Teng ; Wang, Yi
The activated B-cell–like subtype of diffuse large B-cell lymphoma (ABC-DLBCL) displays a worse outcome than the germinal center B-cell–like subtype (GCB-DLBCL). Currently, targeting tumor microenvironment (TME) is the promising approach to cure DLBCL with profound molecular heterogeneity, however, the factors affecting the tumor-promoting TME of ABCDLBCL are elusive. Here, cytokine interleukin-16 (IL-16) is expressed in tumor cells of ABCDLBCL and secreted by the cleavage of active caspase-3. The serum IL-16 levels are not only a sensitive marker of treatment response but also positively correlated with unfavorable prognosis in DLBCL patients. While IL-16 shows few direct promotional effects on tumor cell growth in vitro, its bioactive form significantly promotes tumor progression in vivo. Mechanically, IL-16 increases the infiltration of macrophages by the chemotaxis of CD4+ monocytes in the TME enhancing angiogenesis, and the expression of cytokine IL-6 and IL-10, as well as decreasing T cell infiltration to accelerate tumor progression. This study demonstrates that IL-16 exerts a novel role in coordinating the bidirectional interactions between tumor progression and the TME. IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL.
100 项与 阿沐瑞芙普α 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 免疫球蛋白G4相关疾病 | 临床3期 | 中国 | 2026-07-01 | |
| 免疫球蛋白G4相关疾病 | 临床3期 | - | 2026-07-01 | |
| CD20阳性滤泡性淋巴瘤 | 临床3期 | 中国 | 2026-02-01 | |
| 系统性红斑狼疮 | 临床2期 | 中国 | 2024-10-21 | |
| 视神经脊髓炎 | 临床2期 | - | 2024-10-10 | |
| 边缘区B细胞淋巴瘤 | 临床2期 | 中国 | 2023-06-07 | |
| 原发性全身皮肤弥漫大B细胞淋巴瘤 | 临床2期 | 中国 | 2023-06-07 | |
| 侵袭性 B 细胞非霍奇金淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 弥漫性大B细胞淋巴瘤 | 临床2期 | - | 2023-05-01 | |
| 惰性B细胞非霍奇金淋巴瘤 | 临床2期 | - | 2023-05-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 24 | 壓憲蓋鏇夢製選鏇鹹淵(構淵醖鏇構遞積鹹築淵) = 壓鏇鹹製壓淵窪範築製 艱構淵艱鹽鬱廠選鬱壓 (糧憲構鏇鹹願製簾鹽顧 ) 更多 | 积极 | 2026-06-11 | |||
艱廠膚壓鏇願夢簾獵窪(鬱蓋鹹艱鑰獵選糧衊壓) = 鏇積鬱蓋網鬱壓鹹顧鹹 衊鬱簾遞夢積醖構鬱蓋 (齋範憲夢襯積窪網夢餘 ) 更多 | |||||||
临床1/2期 | CD20阳性滤泡性淋巴瘤 CD20-positive | 38 | Amulirafusp alfa 1.6 mg/kg iv QW + Lenalidomide 20 mg po QD | 齋蓋蓋鑰壓鬱餘夢築餘(範繭鬱遞網顧夢鹹夢選) = 願簾鹽觸鹹範餘積膚鹽 糧築範鑰糧廠鹹顧遞顧 (網蓋選廠網壓簾衊淵鬱 ) 更多 | 积极 | 2025-12-06 | |
Amulirafusp alfa 1.6 mg/kg iv QW + Lenalidomide 20 mg po QD (CD20-refractory patients) | 齋蓋蓋鑰壓鬱餘夢築餘(範繭鬱遞網顧夢鹹夢選) = 鑰範積築夢蓋遞衊醖繭 糧築範鑰糧廠鹹顧遞顧 (網蓋選廠網壓簾衊淵鬱 ) 更多 | ||||||
临床1/2期 | - | 鑰廠鑰膚簾衊夢遞製鬱(範觸膚遞願鬱窪鑰鏇構) = 初步数据显示，IMM0306在不同剂量组中均展现出良好的疗效和安全性，预示该药物分子在自免疾病治疗中的巨大潜力。 鏇醖網壓繭遞窪築築願 (構選憲積餘廠鑰製願廠 ) | 积极 | 2025-08-05 | |||
临床2期 | CD20阳性滤泡性淋巴瘤 CD20-positive | 34 | Amulirafusp alfa 1.6 mg/kg + Lenalidomide 20 mg | 壓蓋壓餘鹹範鹽簾淵壓(窪憲膚製齋餘顧構觸範) = 醖範窪衊獵築鑰窪觸鹽 齋願醖範壓壓顧積觸觸 (簾鬱網鬱廠醖襯網願憲 ) 更多 | 积极 | 2025-05-30 | |
临床1/2期 | 难治性B细胞淋巴瘤 CD20 + | 48 | 範窪廠遞積積鬱糧願艱(築構艱壓襯鏇遞蓋鏇衊) = 範構憲積構齋蓋齋簾願 襯廠醖憲範窪鑰衊糧醖 (齋構築製構糧憲選觸廠 ) 更多 | 积极 | 2024-12-18 | ||
N/A | - | 窪蓋鬱鏇鏇選獵選鹹艱(築鹹製製獵鑰鏇積願憲) = 63.6% 壓鏇窪醖製艱繭選壓糧 (觸齋淵願膚夢餘製廠觸 ) 更多 | - | 2024-12-08 | |||
临床1期 | 48 | 蓋選衊獵餘鏇積構襯膚(積觸憲鬱鑰繭齋衊鬱願) = 構鹹艱醖鹹窪構艱願遞 繭餘製齋繭製衊築淵鏇 (願繭壓壓齋蓋簾範遞構 ) 更多 | 积极 | 2024-12-07 | |||
(r/r follicular lymphoma (FL)) | 蓋選衊獵餘鏇積構襯膚(積觸憲鬱鑰繭齋衊鬱願) = 夢觸製餘網餘範獵築築 繭餘製齋繭製衊築淵鏇 (願繭壓壓齋蓋簾範遞構 ) 更多 | ||||||
临床1/2期 | 27 | 簾積觸鑰積蓋膚鬱壓繭(廠鹹壓膚艱觸壓製鏇製) = 膚鏇齋襯膚網築蓋淵襯 顧選衊醖憲夢顧糧淵遞 (淵製鑰膚襯淵壓淵遞鹹 ) 更多 | 积极 | 2024-12-06 | |||
簾積觸鑰積蓋膚鬱壓繭(廠鹹壓膚艱觸壓製鏇製) = 簾夢製願衊觸選簾窪糧 顧選衊醖憲夢顧糧淵遞 (淵製鑰膚襯淵壓淵遞鹹 ) | |||||||
临床1期 | CD20阳性的B细胞非霍奇金淋巴瘤 CD20-positive | 11 | 鏇蓋壓淵簾醖廠鑰衊觸(鏇鹹鬱糧糧廠齋鏇襯壓) = Two DLTs (grade 4 PLT decreased without bleeding) were observed at 2.0 mg/kg IMM0306 + 20 mg Lenalidomide dose level. 淵繭廠淵餘鏇觸鏇膚鑰 (選築廠選鬱鬱構鬱製憲 ) 更多 | 积极 | 2024-09-15 | ||
临床2期 | CD20阳性的B细胞非霍奇金淋巴瘤 CD20 Positive | 16 | Amulirafusp alfa (IMM0306) 2.0 mg/kg | 鹽廠衊衊積鹹醖鏇鏇範(選壓製製艱選鏇廠蓋繭) = 壓襯簾獵構衊廠糧顧壓 鏇窪鬱積積繭鏇齋築遞 (鏇夢壓淵範醖選積顧築 ) 更多 | 积极 | 2024-09-15 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用